Facility, in response to suit, denies responsibility in death

Mar. 5, 2013

The clinic is at the site of Saint Thomas Hospital. / Alan Poizner / File

Written by

Walter F. Roche Jr.

The Tennessean

Lawyers for the clinic where dozens of patients were injected with tainted spinal steroids say the FDA and state officials in Tennessee and Massachusetts bear responsibility for the fatal outbreak of fungal meningitis.

In a 55-page response to a suit pending in Davidson County Circuit Court, lawyers for the Saint Thomas Outpatient Neurosurgery Center say the facility “complied with the acceptable standard of professional practice and acted without wrongdoing” in selecting a Massachusetts firm as the source of drugs.

“The defendants deny that Ms. Reed is entitled to any recovery,” the filing submitted by lawyers with Gideon, Cooper & Essary states.

The filing came in a lawsuit filed by Wayne Reed, whose wife and caregiver, Diana Reed, died from fungal meningitis after treatment at the clinic. Reed died Oct. 3, after receiving three injections of methylprednisolone acetate at the Nashville clinic.

In addition to the government agencies, the clinic’s response says that the owners and operators of the New England Compounding Center and its sales company bear responsibility. The salesmen were identified as John Notarianni and Mario Giamei of Medical Sales Management, NECC’s sales arm.

NECC, the filing states, engaged in “negligent and reckless conduct,” and its salesmen “misrepresented to providers that NECC’s products were safe and sterile.”

Clinic attorneys charge that the U.S. Food and Drug Administration failed repeatedly to make publicly available findings that signaled the Massachusetts company was not in compliance with sterility and other standards.

The filing denies that the clinic was under any obligation to visit the compounding facility or to investigate whether any of its products had ever been recalled.

Clinic officials “were not required to foresee that NECC would sell them contaminated methyprednisolone acetate,” the answer states.

The Tennessee Health Department, the filing says, was responsible for any delays in notifying patients of the outbreak. The clinic “relied upon and promptly complied with all instructions from the Tennessee Department of Health and the Centers for Disease Control and Prevention.”

The clinic attorneys also deny that the steroids were actually sold to Reed and other patients, and they are asking that Reed’s claims under the state product liability law be dismissed. Rather, the answer states, the suit is a medical claim and should be subject to the limits set in the state’s new tort claims statute.

'Comparative fault'

The clinic’s lawyers cite both the Massachusetts and Tennessee pharmacy boards for failing to properly regulate the company. They assert “comparative fault” against the agencies.

James F. Blumstein, a Vanderbilt University professor of constitutional law and health policy, said comparative fault is a legal argument for lowering a defendant’s liability.

“It’s an interesting argument,” he said. “They are saying the state may be partly at fault; therefore, that diminishes their percentage of fault. The way the comparative fault system works is if you’re liable for $100 and you’re 70 percent at fault, then the recovery against you can only be $70.”

However, any lawsuit against state and federal governments is not likely to yield any “terrific remedies,” Blumstein said. To sue the FDA, lawyers would have to navigate the federal Tort Claims Act, which waives sovereign immunity in certain instances.

Grievances against the state typically end up not in court, but in the Tennessee Claims Commission. Commissioners appointed to eight-year terms hear cases but are forbidden to award damages more than $300,000 to an individual.

Shelley Walker, a spokeswoman for the state Department of Health, said the agency could not comment on allegations in the court documents because they may become a matter of pending litigation.

Tort reform defended

In a related filing in the case, the state attorney general’s office entered an appearance to defend the state’s new tort reform law. Reed’s attorneys have charged that the limits on claims set by the statute are unconstitutional.

Sharon Curtis-Flair, spokeswoman for Attorney General Robert Cooper, said the office has entered the suit solely for the purpose of defending the state tort claim law and would have no comment on the charges against the state agencies in the Saint Thomas filing.

The outbreak has sickened 720 people nationwide, killing 48 of them, according to the latest numbers released Monday by the CDC. Tennessee has had the most deaths, 14, and the second-most illnesses, 150, behind Michigan.